Prostate AdenocarcinomaNCT01731912
Degarelix Acetate Before and During Radiation Therapy in Treating Patients With Prostate Cancer
A study testing Degarelix, External Beam Radiation Therapy and Laboratory Biomarker Analysis in people with Prostate Adenocarcinoma and Stage IIA Prostate Cancer, run by University of Washington at 1 site in United States.
Trial summary
This pilot clinical trial studies how well degarelix acetate before and during radiation therapy works in treating patients with prostate cancer. Androgens can cause the growth of prostate cancer cells. Drugs, such as degarelix acetate, may lessen the amount of androgens made by the body. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Adenocarcinoma, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer
- What is being tested?
- Degarelix, External Beam Radiation Therapy and Laboratory Biomarker Analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide written informed consent
- Written authorization for use and release of health and research study information has been obtained
- Histologically proven adenocarcinoma of the prostate
- Patients must be candidates for short or long term androgen deprivation in combination with external beam radiation therapy (RT) based on the following criteria:
- Intermediate risk disease: T2b/c, or Gleason 7, or prostate-specific antigen (PSA) 10-20
- High risk disease: Gleason 8-10, or PSA > 20, or T3/4
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- Patients may not have received any prior pharmacologic therapy or RT for prostate cancer
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
- Eligibility of patients receiving any medications or substances known to affect or with the potential to affect the androgen axis will be determined following review of their case by the principal investigator
- Patients must allow biopsy at the time of fiducial placement
Who cannot join
- Patients may not be receiving any investigational agents
- Patients who are currently receiving active therapy for other neoplastic disorders will not be eligible
- Patients with histologic evidence of small cell carcinoma of the prostate will not be eligible
- Patients with hypogonadism or severe androgen deficiency as defined by serum testosterone less than 100 ng/dL will not be eligible
- History of pituitary dysfunction
- Patients who are receiving any androgens, estrogens or progestational agents, or who received any of these agents within the 6 months prior to evaluation will not be eligible
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- Patients who are taking drugs which affect androgen metabolism (e.g. spironolactone, ketoconazole, finasteride, dutasteride) will not be eligible; patients who received any of these agents within the 6 months prior to evaluation will be reviewed for eligibility by the principal investigator on a case by case basis
- Patients with inflammatory bowel disease or other autoimmune conditions which might affect the radiated colon or rectum
- Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris, cardiac arrhythmia which is symptomatic or requires active therapy, recent deep venous thrombosis, pulmonary emboli, cerebrovascular accident or ischemia will not be eligible
- Patients with dementia/psychiatric illness/social situations that would limit compliance with study requirements or would prohibit the understanding and/or giving of informed consent will not be eligible
- Patients with medical conditions, which, in the opinion of the investigators, would jeopardize either the patient or the integrity of the data obtained will not be eligible
- Other active malignancy, except non-melanoma skin cancer and superficial bladder cancer
- Patients unwilling to use contraceptives while on study
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Degarelix Acetate Prior to Radiation Therapy
This pilot clinical trial studies how well degarelix acetate before and during radiation therapy works in treating patients with prostate cancer. Androgens can cause the growth of prostate cancer cells. Drugs, such as degarelix acetate, may lessen the amount of androgens made by the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving degarelix acetate together with radiation therapy may work better in treating prostate cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the effect of neoadjuvant degarelix (degarelix acetate) on prostate dihydrotestosterone (DHT) and testosterone levels.
SECONDARY OBJECTIVES:
- To determine the effect of degarelix acetate on androgen-regulated gene expression and apoptosis as assessed by immunohistochemistry, complementary deoxyribonucleic acid (cDNA) microarray analysis and reverse transcriptase (RT)-polymerase chain reaction (PCR).
II. To determine the effect of degarelix acetate on follicle stimulating hormone (FSH) and FSH receptor expression in prostate cancer and surrounding microenvironment.
OUTLINE:
Patients receive degarelix acetate subcutaneously (SC) on day 1. Treatment repeats every 4 weeks for up to 6 courses. Beginning at week 15, patients also undergo standard external beam radiation therapy (EBRT) for 8.5 weeks.
- Conditions
- Prostate Adenocarcinoma, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer, Stage III Prostate Cancer, Stage IV Prostate Cancer
- Being tested
- Degarelix, External Beam Radiation Therapy, Laboratory Biomarker Analysis
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DegarelixDrug
Also called FE200486, Firmagon
Given SC
External Beam Radiation TherapyRadiation
Also called Definitive Radiation Therapy, EBRT, External Beam Radiotherapy, External Beam RT
Undergo standard EBRT
Laboratory Biomarker AnalysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (degarelix acetate, EBRT) | Experimental | Patients receive degarelix acetate SC on day 1. Treatment repeats every 4 weeks for up to 6 courses. Beginning at week 15, patients also undergo standard EBRT for 8.5 weeks. Receives: Drug: Degarelix; Radiation: External Beam Radiation Therapy; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue Levels of DHT in Prostate Tissue as Measured by Mass Spectometry
Differences in tissue androgen levels between this group and historical comparisons will be evaluated by performing a one-way analysis of variance (ANOVA), followed by pair-wise two-sample t-tests to determine which groups are statistically different.
Measured: At week 24
Tissue Levels of Testosterone in Prostate Tissue as Measured by Mass Spectometry
Measured: At week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2012 (estimated)
- Study startMay 2013
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Bruce Montgomery, University of Washington
- Investigators
- Robert Montgomery, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01731912
- Sponsor's protocol ID
- 7846
- Other IDs
- NCI-2012-02136, RAD2, 7846, P30CA015704
- Status last verified
- Dec 2018
- First submitted
- 19 Nov 2012
- Last updated
- 18 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Degarelix Acetate Prior to Radiation Therapy
- ClinicalTrials.gov ID
- NCT01731912
- Acronym / sponsor ID
- 7846
- Conditions
- Prostate Adenocarcinoma, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer, Stage III Prostate Cancer, Stage IV Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 22 Nov 2012 (estimated)
- Results
- Posted 18 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot clinical trial studies how well degarelix acetate before and during radiation therapy works in treating patients with prostate cancer. Androgens can cause the growth of prostate cancer cells. Drugs, such as degarelix acetate, may lessen the amount of androgens made by the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving degarelix acetate together with radiation therapy may work better in treating prostate cancer.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the effect of neoadjuvant degarelix (degarelix acetate) on prostate dihydrotestosterone (DHT) and testosterone levels.
SECONDARY OBJECTIVES:
- To determine the effect of degarelix acetate on androgen-regulated gene expression and apoptosis as assessed by immunohistochemistry, complementary deoxyribonucleic acid (cDNA) microarray analysis and reverse transcriptase (RT)-polymerase chain reaction (PCR).
II. To determine the effect of degarelix acetate on follicle stimulating hormone (FSH) and FSH receptor expression in prostate cancer and surrounding microenvironment.
OUTLINE:
Patients receive degarelix acetate subcutaneously (SC) on day 1. Treatment repeats every 4 weeks for up to 6 courses. Beginning at week 15, patients also undergo standard external beam radiation therapy (EBRT) for 8.5 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (degarelix acetate, EBRT) | Experimental | Drug: Degarelix, Radiation: External Beam Radiation Therapy, Other: Laboratory Biomarker AnalysisPatients receive degarelix acetate SC on day 1. Treatment repeats every 4 weeks for up to 6 courses. Beginning at week 15, patients also undergo standard EBRT for 8.5 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Willing and able to provide written informed consent
- Written authorization for use and release of health and research study information has been obtained
- Histologically proven adenocarcinoma of the prostate
- Patients must be candidates for short or long term androgen deprivation in combination with external beam radiation therapy (RT) based on the following criteria:
- Patients may not have received any prior pharmacologic therapy or RT for prostate cancer
Key exclusion criteria (13 listed)
- Patients may not be receiving any investigational agents
- Patients who are currently receiving active therapy for other neoplastic disorders will not be eligible
- Patients with histologic evidence of small cell carcinoma of the prostate will not be eligible
- Patients with hypogonadism or severe androgen deficiency as defined by serum testosterone less than 100 ng/dL will not be eligible
- History of pituitary dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DegarelixAlso: FE200486, FirmagonGiven SC | Drug | Treatment (degarelix acetate, EBRT) |
| External Beam Radiation TherapyAlso: Definitive Radiation Therapy, EBRT, External Beam Radiotherapy, External Beam RTUndergo standard EBRT | Radiation | Treatment (degarelix acetate, EBRT) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (degarelix acetate, EBRT) |
Primary outcome
Tissue Levels of DHT in Prostate Tissue as Measured by Mass Spectometry
Time frame: At week 24
Differences in tissue androgen levels between this group and historical comparisons will be evaluated by performing a one-way analysis of variance (ANOVA), followed by pair-wise two-sample t-tests to determine which groups are statistically different.
Tissue Levels of Testosterone in Prostate Tissue as Measured by Mass Spectometry
Time frame: At week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Montgomery principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Degarelix, External Beam Radiation Therapy and Laboratory Biomarker Analysis in people with Prostate Adenocarcinoma and Stage IIA Prostate Cancer, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tissue Levels of DHT in Prostate Tissue as Measured by Mass Spectometry (time frame: At week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2019; AzTrials last refreshed its copy on 7 Nov 2026.